IRVING, Texas today announced that -- Novation applauds the recent approval by the U.S. Food and Drug Administration of Sicor Biotech's tbo-filgrastim and the important milestone it represents in the continued development of biosimilar pharmaceuticals in the United States. Although approved through a full Biologics License Application and not a formal "biosimilar", this product is expected to fill the same role in clinical practice as subsequent biosimilars that are ultimately approved via the abbreviated pathway, signed into law in 2010. Sicor Biotech is expected to begin marketing tbo-filgrastim in November 2013.
Biosimilars, which are 'highly similar' versions of reference biologics, are currently approved for use in the European Union and other regions. Research suggests that use of biosimilars could result in price decreases of 20 to 30 percent.
"Despite the slower pace of development in the U.S., biosimilars represent a much needed opportunity for lower-cost alternatives to commonly used biologics as hospitals struggle to contain drug related expenditures," said Steven Lucio, PharmD, BCPS, director of clinical solutions, pharmacy, Novation. "Both this product and subsequently approved biosimilars will require a great deal of physician, pharmacist and clinical staff education to ensure appropriate use and meaningful uptake in the US market. Novation is committed to serving as a resource to help healthcare providers prepare for biosimilars and maximize their impact."
The FDA approved Sicor's tbo-filgrastim as a treatment for patients receiving cancer chemotherapy who experience severe neutropenia, a decrease in infection-fighting white blood cells called neutrophils.
